What is the Sterile Device Packaging Compliance

In the United States alone, it is estimated that over 100,000 people die from hospital-acquired infections every year. Of those, 50 percent are estimated to have occurred due to contact with non-sterile medical instruments. More than ever, health care professionals need to make sure that the medical vacuum sealer they use adheres to sterile device packaging guidelines.

In their efforts to minimize hospital-acquired infections, many hospitals and clinics are turning to products that take the guesswork and human error out of the equation.

As the packaging of single-use medical products has become more highly regulated, many have come to see the quality of the packaging of the device as part and parcel of the quality of the product they are using. No matter how great the pacemaker inside the packaging might be, if you are not confident that the pacemaker has remained sterile, it is of no use.

Obviously the greatest risk in maintaining the sterility of the packaging comes from the mishandling. Cuts, slits, tears and even pinholes in the packaging can result in compromised materials. These are often the result of mishandling, but can also occur during transportation or storage. It is important, therefore, that companies are compliant with standards in place to help ensure the quality of their packaging.

ISO 11607 seeks to codify the standards for sterile device packaging for makers of medical vacuum sealer products.

It specifies the requirements and methods for testing materials, preformed sterile barrier systems, sterile barrier systems and packaging that is intended to maintain sterilized medical devices until point of use. It regulates how and when packaging needs to be tested for packaging to be compliant with the international standard.

In their rush to get products to market, some manufacturers ignore ISO 11607 or try to cut corners on its implementation. This can result in improper packaging that either knowingly or unknowingly releases unsafe instruments on the patient. For this reason, packaging design needs to be part of the design process. If an item is to have a shelf life of a year, package testing can take up to six months to verify that the packaging will keep the product sterile for the full shelf-life.

Most important for manufacturers is to develop and implementation plan for testing. This plan should include the sample size to be tested, the length of time for testing, the scope of testing and establish the criteria for a successful test.

In seeking to eliminate the human element, many companies are turning to new technologies in the medical vacuum sealer industry.

Units like the Fuji Impulse MS-451PV have self-testing features built-in. The MS-451PV will execute a Peel Tensile Test on items being sealed. The strength of the seal is important not only to keeping items properly sterile, but too strong a seal can also inhibit opening of the packaging. With the MS-451PV, testing starts at a pre-determined frequency. All data from the test is output to your PC, and if the test does not meet established criteria, the unit will discontinue its present operation.

The MS-451PV also contains a Visual Inspection Unit. Using 3x magnification and an LED lighting structure, the unit provides an in-process evaluation model to check the seal surface for integrity and strength. Otherwise imperceptible defects such as wrinkles, bubbles or pinholes can be easily detected, catching serious packaging errors before products reach the open market.

While the Peel Tensile Test and Visual Inspection Unit contained on the unit are not meant to be a complete evaluation of the packaging’s integrity, they can be an important step in an overall effective test protocol. It allows individual packages to be verified at the point of seal, and is an important tool for all medical product workers.

For some hospitals and clinics that are using medical vacuum sealer technology that may be 50 years old, upgrading their technology to units like the MS-451PV can represent a giant leap forward in helping to prevent the staggering amount of hospital-acquired infections that result every year.